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Active Not Recruiting
NCT05520099
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
Conditions: Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder, Kidney Cancer, Clear Cell Renal Cell Cancer (ccRCC), Colorectal Cancer, MSI-H Colorectal Cancer, DMMR Colorectal Cancer, Head and Neck Cancer (H&N), Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Liver Cancer, Hepatocellular Carcinoma (HCC), Lung Cancer (NSCLC), NSCLC (Non-small Cell Lung Cancer), Skin Cancer, Cutaneous Melanoma, Endometrial Cancer, Solid Tumor Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 416
Sponsor: Elephas
Location: CARTI Cancer Center Little Rock Arkansas
Summary
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
Eligibility Criteria
Inclusion Criteria --
1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Age ≥ 18 years at the time of consent.
3. Subjects must meet one of the following criteria:
* Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer:
* Bladder: Urothelial Carcinoma (UC)
* Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)
* Subjects suspected or diagnosed with recurrent or metastatic cancer:
* Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
* Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
* Liver: Hepatocellular Carcinoma
* Lung: Non-small cell lung cancer (NSCLC)
* Skin: Cutaneous Melanoma, excluding Uveal Melanoma
* Uterus: endometrial cancer
* Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy:
o Skin: Cutaneous Melanoma, Stage III
* Subjects suspected or diagnosed with:
* Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting
* Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
* Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.
4. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.
Exclusion Criteria --
1. Subjects who are pregnant
2. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
3. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
4. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial
Source: ClinicalTrials.gov (NCT05520099). StuddyBuddy aggregates publicly available trial information.